This is an observational study of pain and outcomes from patients undergoing transgastric NOTES removal of their appendix or gallbladder. Subjects who elect to have a transgastric NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following:

Subjects will complete a 7 day pain/temperature log after surgery

Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction

Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.

The appendix will be removed through an incision in the stomach and pulled out through the mouth

2

Group #2 NOTES Cholecystectomy - Transgastric approach

Procedure: Transgastric Cholecystectomy

The gallbladder will be removed through an incision in the stomach and pulled out through the mouth.

Eligibility

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

There will be 2 groups in this study: Of special note, the inclusion criteria clearly states subjects must be seen within 36 hours of the onset of pain and have an ASA Classification of I. This is intended to avoid obtaining informed consent from a subject who is in severe pain and incapable of making an informed decision, as well as avoid coercion. An ASA Classification of I defines a healthy normal individual.

Group 1 will be transgastric laparoscopic assisted appendectomy

Group 2 will be transgastric laparoscopic assisted cholecystectomy

Criteria

Inclusion criteria for the Group #1 transgastric appendectomy:

Males and Females between the ages of 18-75

Clinical diagnosis of appendicitis Emergency room evaluation within 36 hours of the onset of pain

ASA classification I

Mentally competent to give informed consent.

Scheduled to undergo a transgastric NOTES appendectomy.

Exclusion criteria for group #1 transgastric appendectomy:

Pregnant women

Morbidly obese patients (Body mass index > 35)

Patients who are taking immunosuppressive medications or are immunocompromised

Patients who are on Proton Pump Inhibitors (PPI)

Patients with evidence of an abdominal abscess or mass on CT scan

Patients who present with a clinical diagnosis of sepsis

Patients who have a history of open abdominal surgery

Patients with diffuse peritonitis

Patients on blood thinners or aspirin

Inclusion criteria for Group #2 transgastric cholecystectomy:

Males and Females between the ages of 18 -75

Diagnosis of gallstone disease that require cholecystectomy

ASA classification I

Mentally competent to give informed consent.

Scheduled to undergo a transgastric NOTES cholecystectomy.

Exclusion criteria for Group #2 transgastric cholecystectomy:

Pregnant women

Patients with a Body mass index > 35

Patients who are taking immunosuppressive medications or are immunocompromised

Patients who are on Proton Pump Inhibitors (PPI)

Patients with suspicion of gallbladder cancer

Patients with a history of open abdominal surgery

Patients with known common bile duct stones (gallstones are not limited to the gallbladder)

Patients on blood thinners or aspirin

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531219